Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)

NCT02605486 | Active Not Recruiting Phase 1

• 1 other identifier: 15-207
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer.

Conditions

Metastatic Breast Cancer (MBC)

Keywords

palbociclib; bicalutamide; AR(+); 15-207

Outcome Measures

Primary Outcomes (2)

• recommended phase II dose (RP2D) (phase I)

  We will use a standard 3+3 design for the dose finding lead in to establish the recommended phase II doses for the combination of palbociclib and bicalutamide.

  1 year

• progression free survival (phase II)

  Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v 1.1 criteria.

  6 monthis

Secondary Outcomes (4)

• Objective response rate (CR+PR)

  1 year

• Clinical benefit rate (CBR)

  ≥24 weeks

• Progression-free survival

  1 year

• Safety and Tolerability by assessing the number of subjects with adverse events

  1 year

Study Arms (1)

Palbociclib in Combination with Bicalutamide

EXPERIMENTAL

This is a non-randomized, open-label, phase I/II trial for patients with AR(+) MBC . There will be a dose finding phase I portion of the study to establish the recommended phase II dose (R2PD). This will be followed by a phase II where efficacy is evaluated. Patients with AR(+)ER(-) breast cancer treated on the phase I at the recommended phase II dose will be counted towards the primary endpoint analysis for the phase II study.

Drug: Palbociclib; Drug: Bicalutamide

Interventions

Palbociclib DRUG

Palbociclib in Combination with Bicalutamide

Bicalutamide DRUG

Palbociclib in Combination with Bicalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient will be eligible for androgen receptor expression testing (STEP 1) if the following criteria are met:
• Female
• Pathologically confirmed invasive cancer of the breast
• ER/PR status (ER or PR defined as positive if ≥1%; ER/PR is defined as negative if \<1%):
• Phase I: Patients may have ER/PR(-) breast cancer.
• HER2 normal (IHC 0-1; FISH \< 2.0)
• Non-measurable or measurable, metastatic disease
• Available tissue for AR testing for research purposes
• A patient will be eligible for participation in the therapeutic trial (STEP 2) if the following criteria are met:
• Androgen receptor expression testing confirms that the patient's tumor is AR (+). AR is considered positive if ≥1% of cell nuclei are immunoreactive using the Dako antibody (clone AR441). Receptor testing may be performed on either primary tumor specimen or tissue from a metastatic site. Local testing permitted for eligibility but will require confirmation at MSKCC.
• There is no limit to the number of prior chemotherapy or endocrine therapy regimens allowed. Patients with ER(+) AR(+) breast cancer must have had at least 1 prior line of endocrine therapy to be eligible for the phase I portion of the trial.
• At least 2 weeks since last cytotoxic chemotherapy, hormonal therapy, or radiotherapy. Toxicities related to prior therapy must either have returned to grade 1, or baseline (excluding alopecia)
• Patient may receive bisphosphonates/denosumab for the palliation of bone metastases
• If patient has a history of brain metastases or leptomeningeal disease, lesions must be stable for at least 3 months (as documented by either head CT or brain MRI)
• Prior treatment with bicalutamide will not be allowed

You may not qualify if:

• Patients who have not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1.
• Patients receiving any other investigational anti-cancer agents.
• Patients who have received prior treatment with a selective CDK4/6 inhibitor
• Patients who have received prior anti-androgen therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.
• Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, uncontrolled atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women and women who are breast-feeding.
• Patients with a history of long-QT syndrome or documented family history of long-QT syndrome. Patients who must remain on drugs that prolong the QT interval.
• Palbociclib is a substrate of CYP3A. Caution should be exercised when dosing palbociclib concurrently with CYP3A inducers or inhibitors. Furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Pfizer: collaborator

Study Sites (5)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; bicalutamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ayca Gucalp, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 16, 2015
• Study Start: November 11, 2015
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (5)